LSL · Class II · 21 CFR 866.3390

FDA Product Code LSL: Dna-reagents, Neisseria

Leading manufacturers include Gen-Probe, Inc., Becton, Dickinson & CO and Roche Molecular Systems, Inc..

45
Total
45
Cleared
215d
Avg days
1987
Since
45 devices
25–45 of 45
Cleared Mar 14, 2005
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE
K043144
Gen-Probe, Inc.
Microbiology · 119d
Cleared Dec 31, 2003
GEN-PROBE APTIMA COMBO 2 ASSAY
K032554
Gen-Probe, Inc.
Microbiology · 134d
Cleared Dec 24, 2003
TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS
K032194
Gen-Probe, Inc.
Microbiology · 159d
Cleared Sep 18, 2001
BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY
K012351
Becton, Dickinson & CO
Microbiology · 55d
Cleared May 21, 2001
GEN-PROBE APTIMA COMBO 2 ASSAY
K003395
Gen-Probe, Inc.
Microbiology · 201d
Cleared Feb 29, 2000
HYBRID CAPTURE II CT/GC TEST
K981567
Digene Corp.
Microbiology · 669d
Cleared Dec 01, 1999
ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K974503
Roche Molecular Systems, Inc.
Microbiology · 733d
Cleared Nov 29, 1999
HYBRID CAPTURE II GC-ID
K981485
Digene Corp.
Microbiology · 584d
Cleared Nov 04, 1999
BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY
K984631
Becton Dickinson Microbiology Systems
Microbiology · 309d
Cleared Aug 11, 1999
GONOSTAT GONOCOCCAL DETECTION KIT
K991268
Sierra Diagnostics
Microbiology · 120d
Cleared May 28, 1999
ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K974342
Roche Molecular Systems, Inc.
Microbiology · 556d
Cleared May 06, 1996
LCX NEISSERIA GONORRHOEAE ASSAY
K935833
Abbott Laboratories
Microbiology · 881d
Cleared Oct 31, 1994
GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR
K940979
Gen-Probe, Inc.
Microbiology · 244d
Cleared Apr 26, 1994
PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY
K920301
Gen-Probe, Inc.
Microbiology · 826d
Cleared Nov 14, 1989
ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.
K895583
Gen-Probe, Inc.
Microbiology · 60d
Cleared Apr 25, 1988
PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS
K881277
Gen-Probe, Inc.
Microbiology · 38d
Cleared Mar 01, 1988
GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE
K874620
Gen-Probe, Inc.
Microbiology · 113d
Cleared Dec 21, 1987
GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST
K872628
Ortho Diagnostic Systems, Inc.
Microbiology · 168d